On August 14, 2019 Heat Biologics, Inc. (Nasdaq:HTBX), a biopharmaceutical company developing therapeutics designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the second quarter ended June 30, 2019 (Press release, Heat Biologics, AUG 14, 2019, View Source [SID1234538761]).

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Jeff Wolf, Heat’s CEO, commented, "We recently announced that we completed recruitment for our Phase 2 clinical trial investigating HS-110 for advanced non-small cell lung cancer (NSCLC) in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo (nivolumab) or with Merck’s KEYTRUDA (pembrolizumab) with approximately 120 patients enrolled in the trial. Importantly, we reported promising interim results from the study showing that the addition of HS-110 to nivolumab may restore anti-tumor activity in patients whose disease has progressed after checkpoint inhibitor therapy. Our data showing tumor shrinkage in 35% of patients and disease control in 55% of patients whose disease has progressed after treatment with a checkpoint inhibitor (CPI) supports our mechanistic hypothesis that the broad, T-cell mediated immune response activated by HS-110 may reestablish positive clinical outcomes for patients who have lost the benefit of treatment with a CPI. We are encouraged by the positive results and look forward to reporting additional data later this year."

"Earlier this week, we announced that the FDA has cleared our Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of HS-130, in combination with HS-110, for patients with advanced solid tumors refractory to standard of care. Up to 30 patients are expected to be enrolled in the trial. HS-130 is the first allogeneic, "off-the-shelf" cell line engineered to express the extracellular domain of OX40 ligand fusion protein (OX40L-Fc), a key costimulator of T cells, with the potential to augment antigen-specific CD8+ T cell response."

"We ended the quarter with approximately $19.5 million of cash, cash equivalents and short-term investments. These funds combined with an additional $6.9 million in grant funds from Cancer Prevention Research Institute of Texas (CPRIT) that we expect to receive after filing our IND for PTX-35 should provide us sufficient capital to fund Heat through our HS-110 data release, as well as other clinical programs."

Second Quarter 2019 Financial Results

Recognized $0.3 million of grant revenue for qualified expenditures under the CPRIT grant.
Research and development expenses decreased approximately 2% to $3.4 million for the quarter ended June 30, 2019 compared to $3.5 million for the quarter ended June 30, 2018. The decrease of approximately $56,000 is due to the lower PTX-35 expense for 2019, primarily reflecting decreased manufacturing costs, offset by the increased enrollment in the Phase 2 portion of our multi-arm NSCLC clinical trial and stock-based compensation.
General and administrative expense increased approximately 37% to $1.9 million for the quarter ended June 30, 2019 compared to $1.4 million for the quarter ended June 30, 2018. The $0.5 million increase is primarily attributable to increased personnel costs, including stock-based compensation expense.
Net loss attributable to Heat Biologics was approximately $4.8 million, or ($0.14) per basic and diluted share for the quarter ended June 30, 2019 compared to a net loss of approximately $3.8 million, or ($0.26) per basic and diluted share for the quarter ended June 30, 2018.
As of June 30, 2019, the Company had approximately $19.5 million in cash, cash equivalents and short investments with an additional $6.9 million in grant funds from Cancer Prevention Research Institute of Texas (CPRIT) that it expects to receive after filing our IND for PTX-35.
About Heat Biologics, Inc.

Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer using of CD8+ "Killer" T-cells. Our T-Cell Activation Platform (TCAP) produces therapies designed to turn "cold" tumors "hot" and be administered in combination with checkpoint therapies and other immuno-modulators to